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Hemophilia With Inhibitors Factor VII Deficiency Acquired Hemophilia Surgery Information About NovoSeven Recombinant Safety SevenSECURE
About Hemophilia With Inhibitors About Inhibitors Daily Considerations Managing Hemophilia with Inhibitors Surgery in Hemophilia with Inhibitors
Overview
What Are Inhibitors?
Who Gets Inhibitors?
Diagnosing an Inhibitor
Talking With a Doctor
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What Are Inhibitors?
To understand what inhibitors are, one has to know something about the immune system, which protects the human body from diseases and other illnesses. One of the things that the immune system does is produce antibodies. Antibodies are cells that detect and fight off foreign substances.
Inhibitors are antibodies that make factor replacement therapy difficult for people with hemophilia. Normally, antibodies help protect the body by recognizing and destroying harmful foreign substances like viruses and bacteria.
When someone is factor VIII - or factor IX - deficient, clotting factor treatment must be brought into the blood through injection or infusion to make up for the factor VIII or factor IX that they are missing. In some cases, their body may not recognize the treatment as a helpful substance, and their immune system will develop antibodies—inhibitors—to it. When these antibodies are present, they attack and neutralize the factor VIII or IX that has been injected or infused. This causes the bleeding to continue.
Inhibitors are not present at birth. They develop only after factor has been introduced into the body.3 Most inhibitors develop in the first 9 to 50 days of factor-replacement therapy, so they are often diagnosed in young children. In rare cases, inhibitors can occur after years of treatment.3

IMPORTANT SAFETY INFORMATION

NovoSeven® was studied in 298 patients with hemophilia A or B with inhibitors treated for 1939 bleeding episodes.

  • The most common side effects in people taking NovoSeven were fever, bleeding, a decrease in the amount of coagulation factor 1, pain from blood collecting in a joint, and high blood pressure
  • People who have ever had a bad reaction to proteins from mice, hamsters, or "bovines" (such as an ox or cow) should not be treated with NovoSeven
  • After taking NovoSeven, some patients have more of a risk of thrombosis, which is when a clot forms in a blood vessel and causes harm. Although the extent of this risk is not known, it is thought to be small. Some patients have conditions that may increase this risk. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury, a type of blood poisoning called septicemia, and crush injury, which is when a body part is crushed or squeezed between heavy or immobile objects. Also, people taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) at the same time that they're taking NovoSeven may be at increased risk for thrombosis.
  • Serious adverse events which may or may not have been related to the use of NovoSeven occurred in 14 of the 298 patients in the initial clinical program. Please see the enclosed prescribing information.
  • There have been no reports of NovoSeven causing bad reactions to "analgesics" (such as pain killers), "antibiotics" (the drugs used to treat infection), or "sedatives" (sleeping pills or tranquillizers).
  • Development of antibodies against Factor VII have been reported in Factor VII deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived factor VII.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
NovoSeven is a registered trademark of Novo Nordisk Health Care AG.
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Hemophilia With Inhibitors Factor VII Deficiency Surgery Information About NovoSeven Recombinant Safety SevenSECURE